ChiCTR2300077725 版本V1.1 版本创建时间2024/06/18 15:44:45 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2300077725 

最近更新日期：

Date of Last Refreshed on：

 2023-11-17 09:22:22 

注册时间：

Date of Registration：

 2023-11-17 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

基于热毒与血瘀的相互作用探索凉血解毒活血方治疗儿童紫癜性肾炎的疗效特点

Public title：

Based on the interaction of heat toxin and blood stasis, to explore the therapeutic effect of Liangxue-jiedu-huoxue Formula on children with Henoch-Schonlein Purpura Nephritis

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于热毒与血瘀的相互作用探索凉血解毒活血方治疗紫癜性肾炎III型患儿的疗效特点

Scientific title：

Based on the interaction of heat toxin and blood stasis, to explore the therapeutic effect of Liangxue-jiedu-huoxue Formula on children with Henoch-Schonlein Purpura Nephritis grade Ⅲ

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

崔勤 

研究负责人：

黄岩杰 

Applicant：

Qin-Cui 

Study leader：

Yan-jie Huang 

申请注册联系人电话：

Applicant telephone：

 +86 178 3717 9263

研究负责人电话：

Study leader's
telephone：

+86 158 3719 0011

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 cq17837179263@163.com

研究负责人电子邮件：

Study leader's E-mail：

 huangyanjie69@163.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

河南省郑州市人民路19号

研究负责人通讯地址：

河南省郑州市人民路19号

Applicant address：

19 Renmin Road, Zhengzhou, Henan, China

Study leader's address：

19 Renmin Road, Zhengzhou, Henan, China

申请注册联系人邮政编码：

Applicant postcode：

 450000

研究负责人邮政编码：

Study leader's postcode：

 450000

申请人所在单位：

河南中医药大学第一附属医院

Applicant's institution：

The First Affiliated Hospital of Henan University of CM

研究负责人所在单位：

河南中医药大学第一附属医院

Affiliation of the Leader：

The First Affiliated Hospital of Henan University of CM

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 2021HL-129-01

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

河南中医药大学第一附属医院伦理委员会

Name of the ethic committee：

Ethics committees of The First Affiliated Hospital of Henan University of CM

伦理委员会批准日期：

Date of approved by ethic committee：

 2021-05-06 00:00:00

伦理委员会联系人：

王春芳

Contact Name of the ethic committee：

Chun-fang Wang

伦理委员会联系地址：

河南省郑州市人民路19号

Contact Address of the ethic committee：

19 Renmin Road, Zhengzhou, Henan, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 371 6628 5929

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

河南中医药大学第一附属医院

Primary sponsor：

The First Affiliated Hospital of Henan University of CM

研究实施负责（组长）单位地址：

河南省郑州市人民路19号

Primary sponsor's address：

19 Renmin Road, Zhengzhou, Henan, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

河南

市(区县)：

郑州

Country：

China

Province：

Henan

City：

Zhengzhou

单位(医院)：

河南中医药大学第一附属医院

具体地址：

河南省郑州市人民路19号

Institution
hospital：

The First Affiliated Hospital of Henan University of CM

Address：

19 Renmin Road, Zhengzhou, Henan, China

经费或物资来源：

河南中医药大学科研资助

Source(s) of funding：

Henan University of Chinese Medicine research funding

研究疾病：

紫癜性肾炎  

Target disease：

Henoch-Schonlein Purpura Nephritis

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

1、验证课题组前期尿蛋白组学筛选出的新月体形成尿生物标志物来源于肾小球局部，并探索出HSPN新月体形成早期炎症和高凝的相关信号通路。 2、证实凉血解毒活血方通过调节炎症和高凝的相关通路分子，降低凝血酶、纤维蛋白和相关炎症因子，抑制MMP9激活导致的肾小球基底膜的降解，减轻系膜细胞和CD44阳性的PEC增生，起到预防和治疗HSPN Ⅱ型和Ⅲ的作用。 3、建立中西医结合治疗HSP、HSPN Ⅱ型和Ⅲ型的治疗方案。  

Objectives of Study：

1. To verify the urinary biomarkers of crescent formation screened by the group's preliminary urinary proteomics originated from local glomerulus,and explore the signaling pathways related to inflammation and hypercoagulation in the early stage of Henoch-Schonlein Purpura Nephritis (HSPN) crescent formation. 2.To confirm that Liangxue-jiedu-huoxue prescription can prevent and treat HSPN grade II and III by regulating the molecules of pathways related to inflammation and hypercoagulation, reducing thrombin, fibrin and related inflammatory factors, inhibiting the degradation of glomerular basement membrane caused by MMP-9 activation, and reducing the proliferation of thylakoid cells and CD44-positive PEC. 3. To establish a treatment protocol for HSP, HSPN grade II and HSPN grade III with a combination of Chinese and Western medicine.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

(1) 符合以上HSP和HSPN中医、西医诊断标准者； (2) 所有入组者年龄在4-16岁之间； (3) HSP患儿病程≤1月，留取血、尿标本前未予治疗； (4) HSPN患儿病程≤2月，HSPN肾活检病理诊断为HSPN Ⅱ级、HSPN Ⅲ级，以急性病变为主； (5) HSP及HSPN患儿中医辨证均属于血热妄行兼血瘀证； (6) 正常儿童：常规体检未见异常，无过敏性紫癜和肾脏疾病病史； (7) HSPN的患儿均同意行肾穿刺活检术，所入组儿童或家属签署知情同意书。

Inclusion criteria

(1) those who meet the above diagnostic criteria of HSP and HSPN in traditional Chinese medicine and western medicine. (2) all participants are between 4 and 16 years old. (3) the course of disease in children with HSP is less than 1 month, and there is no treatment before taking blood and urine samples. (4) the course of HSPN was less than 2 months. The pathological diagnosis of HSPN renal biopsy was HSPN Ⅱ and HSPN Ⅲ, mainly acute lesions. (5) TCM syndrome differentiation of children with HSP and HSPN belong to the syndrome of blood heat and blood stasis. (6) normal children: no abnormality in routine physical examination, no history of Henoch-Schonlein purpura and kidney disease. (7) all the children with HSPN agreed to undergo renal biopsy, and the children or their family members signed the informed consent form.

排除标准：

(1) 收集尿液时合并感染，或伴有其他慢性疾病者； (2) 收集尿液标本量过少者； (3) HSP患儿病程中出现一过性尿检异常； (4) HSP、HSPN患儿病程中曾出现肝肾功能异常者； (5) HSPN患儿肾活检病理显示肾脏慢性病理改变为主，如大部分肾小球有节段或球性硬化、纤维化新月体、球囊增厚、球囊断裂、肾小管萎缩、间质纤维化。 (6) 对方案中涉及的药物过敏者。 (7) 依从性差，不能按医嘱服药者。

Exclusion criteria：

(1) patients with infection or other chronic diseases when collecting urine. (2) the amount of urine samples collected is too small. (3) transient abnormal urine test occurred in the course of HSP. (4) Children with HSP and HSPN had abnormal liver and kidney function in the course of disease. (5) Renal biopsy in children with HSPN showed mainly chronic pathological changes, such as segmental or globular sclerosis, fibrotic crescent, balloon thickening, balloon rupture, renal tubule atrophy and interstitial fibrosis. (6) for those who are allergic to drugs involved in the program. (7) those who have poor compliance and cannot take medicine according to the doctor's orders.

研究实施时间：

Study execute time：

从 From 2021-01-01 00:00:00至 To 2023-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2021-01-01 00:00:00 至 To 2023-06-30 00:00:00

干预措施：

Interventions：

组别：

正常对照组

样本量：

 20

Group：

NC

Sample size：

干预措施：

无

干预措施代码：

Intervention：

NO

Intervention code：

组别：

HSP组

样本量：

 50

Group：

HSP

Sample size：

干预措施：

无

干预措施代码：

Intervention：

NO

Intervention code：

组别：

HSPN Ⅱ型中西医结合治疗组

样本量：

 50

Group：

HSPN grade II group treated with integrated traditional chinese and western medicine

Sample size：

干预措施：

中医治疗以凉血解毒、活血化瘀为治疗原则，汤药以凉血解毒活血方随症加减，选用天江药业配方颗粒，疗程3个月，每1个月评价一次。4-7岁，1日半1剂，1日2次口服；7-14岁，1日1剂，1日2次口服。具体方药如下：水牛角15g、生地黄10g、牡丹皮6g、黄芩10g、紫草10g、大蓟15g、小蓟15g、茜草10g、川芎5g、赤芍10g、三七3g、徐长卿10g、茯苓10g、甘草6g。伴风热者，加用金银花10g、连翘10g，伴湿热者，若湿热结于上焦，加用木蝴蝶10g、牛蒡子6g；湿热结于中焦，加用藿香15g、薏苡仁12g；湿热结于下焦，加用黄柏10g、金钱草9g。 HSPN西医常规治疗方案：采用2017年中华医学会儿科学分会肾脏病学组制定的常规治疗方案。

干预措施代码：

Intervention：

The treatment of traditional Chinese medicine is based on the principle of cooling blood and detoxification, promoting blood circulation and removing blood stasis. The decoction is treated with cooling blood, detoxification and activating blood circulation, and Tianjiang pharmaceutical formula granules are selected for a course of 3 months, once a month. 4-7 years old, one and a half dose a day, twice a day; 7-14 years old, one dose a day, twice a day. The specific prescriptions are as follows: Buffalo horn 15g, Radix Rehmanniae 10g, Cortex moutan 6g, Scutellaria baicalensis 10g, Radix Scutellariae 10g, thistle 15g, thistle 15g, Rubiao 10g, Chuanxiong 5g, Radix Paeoniae Rubra 10g, Sanqi 3G, Xu Changqing 10g, Poria cocos 10g, licorice 6g. For those with wind-heat, add honeysuckle 10g, forsythia 10g, damp-heat with damp-heat, add wood butterfly 10g, burdock 6g; damp-heat knot in middle coke, add patchouli 15g, Coix seed 12g; damp-heat knot in lower coke, add Phellodendron Phellodendron 10g, Camellia oleifera 9g. The routine treatment scheme of HSPN western medicine: the routine treatment plan made by Nephrology Group of Chinese Medical Pediatrics Association in 2017 was adopted.

Intervention code：

组别：

HSPN Ⅱ型西医治疗组

样本量：

 50

Group：

HSPN grade II group treated with western medicine

Sample size：

干预措施：

HSPN西医常规治疗方案：采用2017年中华医学会儿科学分会肾脏病学组制定的常规治疗方案。 1）病理为HSPN Ⅱa型：对于持续尿蛋白＞0.5∽1g/d·1.73m2，给予贝那普利盐酸盐片（洛丁新）（北京诺华制药有限公司，国药准字H20030514），服药方法：4-7岁，5mg/次，1次/日，8-16岁，10mg/次，1次/日，晨服 2）非肾病水平蛋白尿且病理为HSPN Ⅱb、Ⅲa型：对于持续尿蛋白＞1g/d·1.73m2、GFR>50ml/(min·1.73m2)的患儿给予贝那普利盐酸盐片（洛丁新）联合强的松片 ( 浙江仙琚有限公司，国药准字H33021207)每日1-2mg/kg口服治疗6个月，依据尿蛋白情况减量； 3）肾病水平蛋白尿、肾病综合症、急性肾炎综合症且病理为HSPN Ⅲb型：糖皮质激素（泼尼松1.5-2mg/(kg·d)），口服4周后改为隔日口服4周后渐减量，在使用糖皮质激素基础上应用环磷酰胺静脉冲击疗法，方法为8-12mg/(kg·d)，静脉滴注，连续应用2d，间隔2周为一疗程，每月1次，共6次，环磷酰胺量剂量≤168mg/kg。对环磷酰胺不能耐受者，可选用吗替麦考酚酯（MMF），用量：20-30mg/(kg·d)，分2次口服。

干预措施代码：

Intervention：

The routine treatment scheme of HSPN western medicine: the routine treatment plan made by Nephrology Group of Chinese Medical Pediatrics Association in 2017 was adopted. 1) Pathology was HSPN Ⅱ a: benazepril hydrochloride tablets (Lodingxin) (Beijing Novartis Pharmaceutical Co., Ltd., H20030514) were given to patients with persistent urinary protein > 0.5 1g/ d ·1.73m2. The method of administration was 4-7 years old, 5mg/, once a day, 8-16 years old, 10mg/, once a day, morning service. 2) non-nephrotic albuminuria with HSPN type Ⅱ b and type Ⅲ a: children with persistent proteinuria > 1g/ d ·1.73m2, GFR > 50ml/ (min ·1.73m2) were treated with benazepril hydrochloride tablets (Luodingxin) combined with prednisone tablets (Zhejiang Xianxing Co., Ltd., national medicine H33021207) for 6 months, and the amount was reduced according to the condition of urinary protein. 3) Nephrotic albuminuria, nephrotic syndrome, acute glomerulonephritis syndrome and pathology is HSPN type Ⅲ b: glucocorticoid (prednisone 1. 5-2mg/ (kg ·d)). After 4 weeks oral administration, the dose decreased gradually after 4 weeks of oral administration. On the basis of glucocorticoid, cyclophosphamide was used intravenously with 8-12mg/ (kg ·d) intravenous drip for 2 days with an interval of 2 weeks. Once a month for 6 times, the dose of cyclophosphamide was ≤ 168mg/kg. For those who can't tolerate cyclophosphamide, you can choose mycophenolate mofetil (MMF), the dosage is 20-30mg/ (kg ·d), orally twice.

Intervention code：

组别：

HSPN Ⅲ型中西医结合治疗组

样本量：

 50

Group：

HSPN grade Ⅲ group treated with integrated traditional chinese and western medicine

Sample size：

干预措施：

中医治疗以凉血解毒、活血化瘀为治疗原则，汤药以凉血解毒活血方随症加减，选用天江药业配方颗粒，疗程3个月，每1个月评价一次。4-7岁，1日半1剂，1日2次口服；7-14岁，1日1剂，1日2次口服。具体方药如下：水牛角15g、生地黄10g、牡丹皮6g、黄芩10g、紫草10g、大蓟15g、小蓟15g、茜草10g、川芎5g、赤芍10g、三七3g、徐长卿10g、茯苓10g、甘草6g。伴风热者，加用金银花10g、连翘10g，伴湿热者，若湿热结于上焦，加用木蝴蝶10g、牛蒡子6g；湿热结于中焦，加用藿香15g、薏苡仁12g；湿热结于下焦，加用黄柏10g、金钱草9g。 HSPN西医常规治疗方案：采用2017年中华医学会儿科学分会肾脏病学组制定的常规治疗方案。

干预措施代码：

Intervention：

The treatment of traditional Chinese medicine is based on the principle of cooling blood and detoxification, promoting blood circulation and removing blood stasis. The decoction is treated with cooling blood, detoxification and activating blood circulation, and Tianjiang pharmaceutical formula granules are selected for a course of 3 months, once a month. 4-7 years old, one and a half dose a day, twice a day; 7-14 years old, one dose a day, twice a day. The specific prescriptions are as follows: Buffalo horn 15g, Radix Rehmanniae 10g, Cortex moutan 6g, Scutellaria baicalensis 10g, Radix Scutellariae 10g, thistle 15g, thistle 15g, Rubiao 10g, Chuanxiong 5g, Radix Paeoniae Rubra 10g, Sanqi 3G, Xu Changqing 10g, Poria cocos 10g, licorice 6g. For those with wind-heat, add honeysuckle 10g, forsythia 10g, damp-heat with damp-heat, add wood butterfly 10g, burdock 6g; damp-heat knot in middle coke, add patchouli 15g, Coix seed 12g; damp-heat knot in lower coke, add Phellodendron Phellodendron 10g, Camellia oleifera 9g. The routine treatment scheme of HSPN western medicine: the routine treatment plan made by Nephrology Group of Chinese Medical Pediatrics Association in 2017 was adopted.

Intervention code：

组别：

HSPN Ⅲ型西医治疗组

样本量：

 50

Group：

HSPN grade Ⅲ group treated with western medicine

Sample size：

干预措施：

HSPN西医常规治疗方案：采用2017年中华医学会儿科学分会肾脏病学组制定的常规治疗方案。 1）病理为HSPN Ⅱa型：对于持续尿蛋白＞0.5∽1g/d·1.73m2，给予贝那普利盐酸盐片（洛丁新）（北京诺华制药有限公司，国药准字H20030514），服药方法：4-7岁，5mg/次，1次/日，8-16岁，10mg/次，1次/日，晨服 2）非肾病水平蛋白尿且病理为HSPN Ⅱb、Ⅲa型：对于持续尿蛋白＞1g/d·1.73m2、GFR>50ml/(min·1.73m2)的患儿给予贝那普利盐酸盐片（洛丁新）联合强的松片 ( 浙江仙琚有限公司，国药准字H33021207)每日1-2mg/kg口服治疗6个月，依据尿蛋白情况减量； 3）肾病水平蛋白尿、肾病综合症、急性肾炎综合症且病理为HSPN Ⅲb型：糖皮质激素（泼尼松1.5-2mg/(kg·d)），口服4周后改为隔日口服4周后渐减量，在使用糖皮质激素基础上应用环磷酰胺静脉冲击疗法，方法为8-12mg/(kg·d)，静脉滴注，连续应用2d，间隔2周为一疗程，每月1次，共6次，环磷酰胺量剂量≤168mg/kg。对环磷酰胺不能耐受者，可选用吗替麦考酚酯（MMF），用量：20-30mg/(kg·d)，分2次口服。

干预措施代码：

Intervention：

The routine treatment scheme of HSPN western medicine: the routine treatment plan made by Nephrology Group of Chinese Medical Pediatrics Association in 2017 was adopted. 1) Pathology was HSPN Ⅱ a: benazepril hydrochloride tablets (Lodingxin) (Beijing Novartis Pharmaceutical Co., Ltd., H20030514) were given to patients with persistent urinary protein > 0.5 1g/ d ·1.73m2. The method of administration was 4-7 years old, 5mg/, once a day, 8-16 years old, 10mg/, once a day, morning service. 2) non-nephrotic albuminuria with HSPN type Ⅱ b and type Ⅲ a: children with persistent proteinuria > 1g/ d ·1.73m2, GFR > 50ml/ (min ·1.73m2) were treated with benazepril hydrochloride tablets (Luodingxin) combined with prednisone tablets (Zhejiang Xianxing Co., Ltd., national medicine H33021207) for 6 months, and the amount was reduced according to the condition of urinary protein. 3) Nephrotic albuminuria, nephrotic syndrome, acute glomerulonephritis syndrome and pathology is HSPN type Ⅲ b: glucocorticoid (prednisone 1. 5-2mg/ (kg ·d)). After 4 weeks oral administration, the dose decreased gradually after 4 weeks of oral administration. On the basis of glucocorticoid, cyclophosphamide was used intravenously with 8-12mg/ (kg ·d) intravenous drip for 2 days with an interval of 2 weeks. Once a month for 6 times, the dose of cyclophosphamide was ≤ 168mg/kg. For those who can't tolerate cyclophosphamide, you can choose mycophenolate mofetil (MMF), the dosage is 20-30mg/ (kg ·d), orally twice.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 河南 

市(区县)：

 郑州 

Country：

China

Province：

Henan

City：

Zhengzhou

单位(医院)：

 河南中医药大学第一附属医院 

单位级别：

 三甲医院 

Institution
hospital：

The First Affiliated Hospital of Henan University of CM

Level of the institution：

Grade A tertiary hospital

国家：

 中国

省(直辖市)：

 河南 

市(区县)：

 郑州 

Country：

China

Province：

Henan

City：

Zhengzhou

单位(医院)：

 郑州大学第一附属医院 

单位级别：

 三甲医院 

Institution
hospital：

The First Affiliated Hospital of Zhengzhou University

Level of the institution：

Grade A tertiary hospital

国家：

 中国

省(直辖市)：

 河南 

市(区县)：

 郑州 

Country：

China

Province：

Henan

City：

Zhengzhou

单位(医院)：

 河南省儿童医院 

单位级别：

 三甲医院 

Institution
hospital：

Henan Children's Hospital

Level of the institution：

Grade A tertiary hospital

测量指标：

Outcomes：

指标中文名：

24小时尿蛋白

指标类型：

主要指标

Outcome：

24-h proteinuria

Type：

Primary indicator

测量时间点：

治疗前及治疗1、2、3月各检测1次

测量方法：

尿液检查

Measure time point of outcome：

The test was performed before treatment and 1, 2 and 3 months after treatment.

Measure method：

Urine tests

指标中文名：

尿红细胞

指标类型：

主要指标

Outcome：

Urine red blood cells

Type：

Primary indicator

测量时间点：

治疗前及治疗1、2、3月各检测1次

测量方法：

尿液检查

Measure time point of outcome：

The test was performed before treatment and 1, 2 and 3 months after treatment.

Measure method：

Urine tests

指标中文名：

尿检肾损

指标类型：

主要指标

Outcome：

Urinalysis kidney damage

Type：

Primary indicator

测量时间点：

治疗前及治疗1、2、3月各检测1次

测量方法：

尿液检查

Measure time point of outcome：

The test was performed before treatment and 1, 2 and 3 months after treatment.

Measure method：

Urine tests

指标中文名：

凝血六项

指标类型：

次要指标

Outcome：

Six coagulation items

Type：

Secondary indicator

测量时间点：

治疗前及治疗1、2、3月各检测1次

测量方法：

抽血检查

Measure time point of outcome：

The test was performed before treatment and 1, 2 and 3 months after treatment.

Measure method：

Blood tests

指标中文名：

肿瘤坏死因子α

指标类型：

次要指标

Outcome：

Tumor necrosis factor-α

Type：

Secondary indicator

测量时间点：

治疗前及治疗1、2、3月各检测1次

测量方法：

酶联免疫法

Measure time point of outcome：

The test was performed before treatment and 1, 2 and 3 months after treatment.

Measure method：

ELISA

指标中文名：

凝血酶

指标类型：

次要指标

Outcome：

Thrombin

Type：

Secondary indicator

测量时间点：

治疗前及治疗1、2、3月各检测1次

测量方法：

抽血检查

Measure time point of outcome：

The test was performed before treatment and 1, 2 and 3 months after treatment.

Measure method：

Blood tests

指标中文名：

基质金属蛋白酶9

指标类型：

次要指标

Outcome：

Matrix Metalloproteinase-9

Type：

Secondary indicator

测量时间点：

治疗前及治疗1、2、3月各检测1次

测量方法：

酶联免疫法

Measure time point of outcome：

The test was performed before treatment and 1, 2 and 3 months after treatment.

Measure method：

ELISA

指标中文名：

Ⅳ型胶原

指标类型：

次要指标

Outcome：

Type IV collagen

Type：

Secondary indicator

测量时间点：

治疗前及治疗1、2、3月各检测1次

测量方法：

酶联免疫法

Measure time point of outcome：

The test was performed before treatment and 1, 2 and 3 months after treatment.

Measure method：

ELISA

指标中文名：

CD44

指标类型：

次要指标

Outcome：

CD44

Type：

Secondary indicator

测量时间点：

治疗前及治疗1、2、3月各检测1次

测量方法：

酶联免疫法

Measure time point of outcome：

The test was performed before treatment and 1, 2 and 3 months after treatment.

Measure method：

ELISA

指标中文名：

血常规

指标类型：

副作用指标

Outcome：

routine blood test

Type：

Adverse events

测量时间点：

治疗前及治疗1、2、3月各检测1次

测量方法：

抽血检查

Measure time point of outcome：

The test was performed before treatment and 1, 2 and 3 months after treatment.

Measure method：

Blood tests

指标中文名：

肝肾功能

指标类型：

副作用指标

Outcome：

Liver and kidney function

Type：

Adverse events

测量时间点：

治疗前及治疗1、2、3月各检测1次

测量方法：

抽血检查

Measure time point of outcome：

The test was performed before treatment and 1, 2 and 3 months after treatment.

Measure method：

Blood tests

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

肾组织

组织：

肾脏

Sample Name：

Renal tissue

Tissue：

kidney

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

标本中文名：

血液

组织：

Sample Name：

blood

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

标本中文名：

尿液

组织：

Sample Name：

Urine

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 4 岁 years
最大 Max age 16 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

由统计人员用R 4.2.2软件产生随机数列

Randomization Procedure (please state who generates the random number sequence and by what method)：

Random sequence generated by statisticians using R4.2.2 software

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

双盲（对受试者和研究者均隐藏分组）

Blinding：

Double blind (hidden grouping for both subjects and researchers)

是否共享原始数据：

IPD sharing

是Yes

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

通过电话或邮件联系项目负责人； 临床试验公共管理平台 IPD（http://www.medresman.org.cn）。

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

Contact the project leader by phone or email; ResMan IPD (http://www.medresman.org.cn) .

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

研究数据包括原始数据、病历记录表和网络电子数据

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

The research data include original data, medical record forms and network electronic data

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2023-11-17 09:22:03